What are the responsibilities and job description for the Quality Engineer, DSM Operations (Nights) position at FUJIFILM Biotechnologies?
Position: QA Engineer, DSM Operations (Nights)
Schedule: 1800-0600 in a 2-2-3 cadence
Location: Holly Springs, NC
Company: FUJIFILM Diosynth Biotechnologies
About Us:
FUJIFILM Diosynth Biotechnologies is a global leader in innovation and technology, committed to excellence in the life sciences industry. Our mission is to advance solutions that improve lives while fostering a collaborative and inclusive work environment.
Position Overview:
We are seeking a detail-oriented and dedicated QA Engineer (Nights) to join our DSM Operations team during night shifts. This role is critical in ensuring that our manufacturing processes meet the highest quality standards and comply with regulatory requirements.
Key Responsibilities:
- Perform quality assurance activities to support DSM operations during night shifts.
- Monitor and evaluate manufacturing processes to ensure compliance with established quality standards.
- Conduct investigations for non-conformances, deviations, and CAPAs (Corrective and Preventive Actions).
- Review and approve batch records and associated documentation.
- Collaborate with cross-functional teams to drive continuous improvement initiatives.
- Ensure compliance with FDA, ISO, and other applicable regulatory standards.
- Maintain accurate and detailed documentation of quality activities.
Requirements:
- Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or related discipline).
- At least 6 years of hands-on experience in quality assurance, thriving in GMP-regulated manufacturing environments.
- Strong knowledge of FDA, ISO, and other regulatory standards.
- Excellent problem-solving and analytical skills.
- Effective communication and collaboration abilities.
Why Join Us?
- Work with a global leader in innovation and technology.
- Be part of a team that values quality, collaboration, and continuous improvement.
- Competitive salary and benefits package.
How to Apply:
Ready to contribute to FujiFilm’s mission of excellence? Apply directly through our career portal:
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